DATE: / Nov 2017
POSITION: / Head of Production IT
BUSINESS UNIT: / Almac Clinical Technologies
LOCATION: / UK (Charnwood)
REPORTING TO: / Vice President, Production IT
RESPONSIBLE FOR (PEOPLE): / TBC
OVERALL ROLE OBJECTIVE:
The Director, Production IT will assist the vice president of Production IT and other directors in assessing, creating, improving, and implementing department policies and procedures and will be responsible for the day to day operations of the department, inclusive of departmental delivery, quality, metrics, efficiency and procedural compliance. Will ensure that all studies are delivered in a high quality, efficient and timely manner in accordance to standard operating procedures and business needs.
JOB SPECIFIC RESPONSIBILITIES:
The post holder will:
Operational Business Planning:
• Work with the Vice President, Production IT and other Directors to define, communicate and implement business strategy and objectives for the Production IT department, in line with the overall company strategy.
• Work with peers to ensure that objectives are achieved related to corporate and departmental strategy and short term and long term goals.
• Actively measure progress against goals and perform corrective actions as necessary to ensure goals are met; report progress against goals to executive management team and department.
• Assess, create, improve, and implement department policies and procedures.
• Assume responsibility for the day to day operations of the department, inclusive of departmental metrics, capacity needs, quality, delivery, efficiency and procedural compliance. Will ensure project timeline, quality and profitability goals are met, and will ensure remediation of Production IT issues escalated by Almac team members.
• Ensure that the department remains in step with technical and business advances and is poised to meet development needs resulting from all corporate initiatives
• Define, implement and ensure compliance to formal software development strategies, methodologies and best practices, and assess associated risks; and will identify, and implement department tools and process improvements.
• Assist in defining, implementing, monitoring, assessing and revising risk management processes and deliverables.
· Capacity Assessment, Recruiting and hiring:
o Participates in capacity planning: uses fiscal year goals, sales projections and business development pipeline information to determine technical staffing needs.
o Actively manages staffing needs and develops effective strategies and plans to support the business and workload (headcount requirements, capacity plans).
o Creates strategies to ensure the most efficient and cost effective approach to support production needs.
o Owns departmental technical hiring decisions.
o Works with VP, Director and Departmental Manager(s) to define recruiting strategies/plans, identify needed staff competencies and skillsets, and actively recruit and hire accordingly.
o Works with Human Resources/Recruitment to plan for necessary recruitment activities and process.
o Facilitates new hire on-boarding process.
Production IT:
• Follow and promote the Almac corporate, ‘people’ and leadership values, and actively works to create a high performing culture.
• Responsibility for defining, implementing and ensuring compliance to business, technical and development strategies and standards.
• Responsibility for the day-to-day operations of the department. Provides solution vision and guidance, ensures support and execution.
• Responsibility for delivery and technical quality. Maintains related metrics, assesses trends, and identifies and implements corrective and preventive actions. Tracks production project delivery and risk management using appropriate tools.
• Ensure that project issues are resolved in a timely manner without jeopardizing patient safety and or project timelines
.
• Provide consultation to the business and to clients, as needed.
• Works within the appropriate budget constraints (headcount and otherwise) for staffing and departmental operation.
• Collaborate and coordinate tool development and other projects as required with departmental manager(s).
• Responsibility to ensure delivery efficiency (product, learning curve, strategy, approach, implementation).
• Responsibility for ProdIT proficiency development and control; training (best practice governance, competency development)
• Manage direct reports. Maintains awareness of the status of production projects; guides and assists managers to ensure projects are delivered on-time, on-budget and within expected quality standards. Facilitates as necessary with Clinical Project Services and Quality Assurance as part of on-time project delivery.
• Work with Managers to ensure departmental support strategies and plans are in place to support our business and client teams.
• Measure and report progress on projects and initiatives assigned by the Vice President by gathering, tracking and assessing specific measures, including but not limited to utilization, recovery, efficiency, productivity and quality statistics, delivery dates, and product trends. Analyzes data for trends to continually identify areas of improvement
.
• Owns the Incident Reporting (IR) process within Production IT, inclusive of technical investigation, root cause analysis, impact assessment, CAPA and resolution. Works directly with the Quality Assurance department to address root cause quality issues and remediates as necessary.
• Participate in Quality review meetings and is accountable for action item resolution and implementation.
• Day to day management of ancillary sub-departments as needed, e.g., Data Integrations, Support, etc.
• Represent the Production IT department during audits and owns technical audit responses related to Production IT.
• Identift and communicate technical and operational issues to VP, Production IT and collaborates on solutions.
• Coordinate appropriate resources to enlist and provide feedback to ensure solutions meet the business needs.
• Assist in the implementation of production related solutions.
Process Management:
• Own departmental SOPs and WIs.
• Facilitate the implementation of process and/or efficiency improvements and develops supporting SOPs/WIs, as necessary.
• Create non-production related processes as needed; ensures appropriate communication and/or training occurs with staff.
• Ensure that staff understand and follow/comply with all SOPs/WIs.
• Ensure that CAPAs assigned to Production IT are completed according to requested timeframe.
• Leads and/or participates in company-wide cross-functional initiatives
.
• Communicate and implements process changes.
• Accountable for the assignment, follow up and resolution of any assigned Production IT action items.
• Accountable for quality oversight of all ProductionIT initiative deliverables
• Reviews and approves technical and/or department deviations prior to submission to QA.
• Responsible for the processes used within the Production IT department. Evaluates and reviews processes and identifies solutions to improve and streamline workflow/procedures in order to add efficiency and/or improve quality. Works with QA to implement processes that are compliant with industry regulations.
• Ensures compliance to the production IT phase of the Almac software development lifecycle (SDLC)
• Assists in remediating escalated team issues that require leadership attention in order to get timely resolution.
Operational Support:
· Ensure all corporate and departmental strategies, goals and objectives are understood and met by self and staff.
· Participate in the creation, tracking and dissemination to staff of departmental goals and objectives.
· Ensure that Managers, TSLs/GLs and Solutions Architects provide the support required to achieve departmental goals and objectives.
· Provide support in project team negotiations and assists in adjusting escalated resourcing decisions.
· Support peers in timecard approvals when necessary.
· Collect status and creates and distributes operational reports as required by management.
· Suggest additional metrics collection or assessments to more effectively manage operations.
GENERAL ROLE RESPONSIBILITIES:
Quality / Ensure GMP is adhered to in all areas of work.Health & Safety
/ Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place.Training and Development
/ Ensure training has been received before undertaking specific duties and that all training is recorded in training records.Human Resource Management
/ Adhere to all HR policies and procedures, to include all absence policies and procedures.Communication
/ Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects.Equal Opportunities
/ Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur.Core Competency Framework
/ Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework.By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities identified therein.
EMPLOYEE’S SIGNATURE:
PRINT NAME:
DATE:
This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works. It is not intended to be rigid or inflexible and may alter as the Company’s strategic direction changes.
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PERSON SPECIFICATIONDATE: / Nov 2017
POSITION: / Head of Production IT
BUSINESS UNIT: / Almac Clinical Technologies
LOCATION: / UK (Charnwood)
REPORTING TO: / Vice President, Production IT
RESPONSIBLE FOR (PEOPLE): / TBC
/ ESSENTIAL
REQUIREMENT /
DESIRABLE
REQUIREMENT
/ ASSESSMENT METHODQUALIFICATIONS / Bachelor’s Degree in computer science or information technology discipline or equivalent work experience in technical field, such as computer science or information technology discipline / Master’s Degree in computer science or information technology discipline or equivalent work experience / Application Form and Documentary Evidence
EXPERIENCE / Significant experience of software development
Significant experience managing software development or IT projects
Understanding of both waterfall and agile/SCRUM SDLC disciplines
Understanding of FDA 21 CFR Part 11 as it relates to software development / Significant experience of managing software development or IT projects
Significant experience of clinical trials or related pharmaceutical industry experience
Demonstrated knowledge of the clinical trial process
Understanding of current Microsoft development and SDLC tools
Basic understanding of Object Oriented Design [OOD] principles
Basic understanding of Test-Driven Design [TDD] and testing/code coverage / Application Form and Interview
KEY SKILLS / Proven leadership ability with strong people and motivational skills
Strong communication skills (written and verbal)
Strong interpersonal skills
Strong customer service skills
Strong commitment to fostering and promoting team-work and collaboration
Effective combination of influencing and assertiveness capability
Ability to perform multiple project tasks
Ability to be detail-oriented with an emphasis on accuracy and delivery of high quality projects
Strong strategic thinking, analytical and problem solving skills
Ability to flex with changing work processes, work environment and job needs.
Thorough working knowledge of the Microsoft Office Suite of products. / Psychometric Testing and/or Interview
ALMAC CORE COMPETENCIES
COMPETENCY / BEHAVIOUR /
ASSESSMENT METHOD
RESULTS DELIVERY / Delivers results on time, within constraints and in line with company policy and procedure and organisational strategy. Demonstrates a continuous drive for quality and a commitment to excellence. / InterviewPROACTIVE SOLUTIONS / Analyses and uses experience and logical methods to make sound decisions which solve difficult problems. Seeks practical/workable and innovative methods to deliver solutions. / Interview
LEADS BY EXAMPLE / Promotes a clear vision and mission. Acts as a positive role model for the organisation, fostering a climate of teamwork and development. / Interview
COMMUNICATION / Communicates clearly and effectively. Promotes the exchange of ideas and information across the organisation. Fosters dialogue to ensure everyone understands what is going on. / Interview
CUSTOMER FOCUS / Strives to exceed the expectations and requirements of internal and external customer; acts with customers in mind and values the importance of providing high-quality customer service. / Interview
JOB SPECIFIC KNOWLEDGE / Demonstrates required job knowledge and understanding to successfully and competently fulfill or exceed the requirements of their post. Follows correct procedures and guidelines (SOPs).
Proactively demonstrates a desire to enhance and develop their job knowledge. / Interview
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